FDA Approval Times Best Those of Comparable International Agencies

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Maybe it’s time to show the U.S. Food and Drug Administration (FDA) a little love.

“In 2017, FDA was the agency with the shortest median approval time (243 days), which is likely due to the wide use of facilitated regulatory pathways (FRPs) that year, where 40% of [new active substance (NAS)] approvals were designated as Breakthrough, highlighting the importance of those products in addressing unmet medical need,” according to a new study from the London-based Centre for Innovation in Regulatory Science (CIRS).

The fastest median approval time for FDA was followed by times at the Japan Pharmaceuticals and Medical Devices Agency (PMDA) (333 days), Health Canada (350), the Australian Therapeutic Goods Administration (TGA) (364), the European Medicines Agency (EMA) (419), and Swissmedic (470). In general, the median approval times were similar across the six agencies, where the difference between the fastest and slowest agency (excluding FDA) was 137 days.

Citing “major improvements in the regulatory environment as well as changes in strategies of multinational companies,” the report found a decrease in the time to marketing authorization, as well as an increase in the number of medicines that have become available over the last decade (2008 to 2017) across six major regulatory agencies: EMA, FDA, PMDA, Health Canada, Swissmedic, and TGA. More specifically, the number of common products approved by all six agencies increased from 12 in 2008–12 to 51 in 2013–17.

CIRS found several underlying factors influencing the overall time it takes for a new medicine to be submitted and then approved by an agency. Those include:

  • company strategy
  • the conduct and the type of the review process
  • the type of product and its therapeutic area

Furthermore, size matters. According to the report, “Nevertheless, one of the key factors that may determine the likelihood and timing of submission is the size of the sponsor…where a medicine may be less likely to become internationalized beyond the first country of submission if it is developed by a smaller company.”

The number of FDA Center for Drug Evaluation and Research (CDER) NAS approvals after one cycle increased from 70% in 2008–12 to 84% in 2013–17, CIRS observed. In addition, the proportion of one-cycle reviews was higher for expedited reviews compared to standard reviews in 2013–17. “This reflects CDER efforts to further optimize its review process, particularly by increasing the number of one-cycle approvals,” the report noted.

Author: Michael Causey